CompletedNot Applicable

A Post-market Clinical Study to Collect Safety and Performance Data on Johnson & Johnson Surgical Vision Products

United States, Germany1,674 participantsStarted 2022-06-21

Plain-language summary

Retrospective collection of data from medical records, multicenter, post-market clinical follow-up study.

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patients who have been implanted with and/or undergone ophthalmic surgery using targeted JJSV products
✓. Status post ophthalmic surgery between 1 day and 24 months for Year 1. Subsequent years after Year 1 will be between 1 day and 18 months.

✕. Concurrent participation (during the retrospective follow-up period) in an interventional (drug, device, biologic, etc.) clinical trial
✕. Use of surgical devices not in accordance with the product labeling or indications for use
✕. Degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that cause visual acuity losses to a level worse than 0.2 logMAR (0.63 decimal, 6/9.5 or 20/32 Snellen) during the retrospective data collection period
✕. Use of systemic or ocular medications that may affect vision during the retrospective data collection period
✕. Known ocular disease or pathology that, in the opinion of the investigator may confound study findings during the retrospective data collection period
✕. Pregnancy, lactating, or other condition associated with hormonal fluctuation that could lead to refractive changes during the retrospective data collection period.

Incidence of Adverse Events

Timeframe: up to 12 months post-operation

BCDVA

Timeframe: up to 12 months post-operation

NCT IDNCT05394324

SponsorJohnson & Johnson Surgical Vision, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-05-31

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patients who have been implanted with and/or undergone ophthalmic surgery using targeted JJSV products
✓. Status post ophthalmic surgery between 1 day and 24 months for Year 1. Subsequent years after Year 1 will be between 1 day and 18 months.

✕. Concurrent participation (during the retrospective follow-up period) in an interventional (drug, device, biologic, etc.) clinical trial
✕. Use of surgical devices not in accordance with the product labeling or indications for use
✕. Degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that cause visual acuity losses to a level worse than 0.2 logMAR (0.63 decimal, 6/9.5 or 20/32 Snellen) during the retrospective data collection period
✕. Use of systemic or ocular medications that may affect vision during the retrospective data collection period
✕. Known ocular disease or pathology that, in the opinion of the investigator may confound study findings during the retrospective data collection period
✕. Pregnancy, lactating, or other condition associated with hormonal fluctuation that could lead to refractive changes during the retrospective data collection period.